Effects of Periodontal Treatment on HIV-infected Patients

Not Applicable

Completed

• Conditions: HIV/AIDS; Periodontal Diseases
• Interventions: Procedure: Basic periodontal treatment

• Registration Number: NCT03262402
• Lead Sponsor: University of Sao Paulo

Brief Summary

Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.

Detailed Description

Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes \< 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-02
• Study First Submitted: 2017-08-19
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-25
• Primary Completion: 2018-08-02
• Study Completion: 2019-04-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss >4mm); no use of antibiotics for the 6 months previous to study enrolment.
• For HIV-infected group: CD4 T lymphocytes < 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.

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Exclusion Criteria

• General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-HIV infected group	Basic periodontal treatment	Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
HIV-infected group	Basic periodontal treatment	Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.

Primary Outcome Measures

Name	Time	Method
Change in clinical signs of chronic periodontitis.	Baseline, 30 days and 90 days.	Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.

Secondary Outcome Measures

Name	Time	Method
Change in Candida spp carriage.	Baseline, 30 days and 90 days.	Number of Candida spp colonies on culture plates.
Change in salivary biomarkers	Baseline, 30 days and 90 days.	Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
Change in bacterial microbiota	Baseline, 30 days and 90 days.	Pyrosequencing characterization of the bacterial microbiota

Trial Locations

Locations (1)

School of Dentistry of Ribeirão Preto, University of São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil